PFO ACCESS Registry

Expanded access is currently available for this treatment.
Verified July 2016 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00583401
First received: December 21, 2007
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.

Condition Intervention
Patent Foramen Ovale
Stroke
Device: Device closure with the AMPLATZER PFO Occluder

Study Type: Expanded Access     What is Expanded Access?
Official Title: Patent Foramen Ovale Closure With the AMPLATZER PFO OCCLUDER in Patients With Recurrent Cryptogenic Stroke Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale Who Have Failed Conventional Drug Therapy

Further study details as provided by St. Jude Medical:

Intervention Details:
    Device: Device closure with the AMPLATZER PFO Occluder
    Device closure with the AMPLATZER PFO Occluder
Detailed Description:
The primary objective of the PFO Access Registry is to allow access to the AMPLATZER PFO Occluder in subjects with a PFO who have already experienced at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patent foramen ovale-(PFO)
  • recurrent stroke
  • failed antiplatelet/anticoagulant therapy

Exclusion Criteria:

  • International normalized ration (INR) outside of 2-3 intracardiac thrombus (subjects may be enrolled after resolution of thrombus)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583401

Contacts
Contact: Karen Cook kcook@sjm.com

Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00583401     History of Changes
Obsolete Identifiers: NCT00557479
Other Study ID Numbers: AGA-011  G060145 
Study First Received: December 21, 2007
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
PFO
stroke

Additional relevant MeSH terms:
Stroke
Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 29, 2016